Onchocerciasis: Target product profiles of in vitro diagnostics to support onchocerciasis elimination mapping and mass drug administration stopping decisions

Marco A. Biamonte*, Paul T. Cantey, Yaya I. Coulibaly, Katherine M. Gass, Louise C. Hamill, Christopher Hanna, Patrick J. Lammie, Joseph Kamgno, Thomas B. Nutman, David W. Oguttu, Dieudonné P. Sankara, Wilma A. Stolk, Thomas R. Unnasch

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

In June 2021, the World Health Organization (WHO), recognizing the need for new diagnostics to support the control and elimination of onchocerciasis, published the target product profiles (TPPs) of new tests that would support the two most immediate needs: (a) mapping onchocerciasis in areas of low prevalence and (b) deciding when to stop mass drug administration programs. In both instances, the test should ideally detect an antigen specific for live, adult O. volvulus female worms. The preferred format is a field-deployable rapid test. For mapping, the test needs to be ≥ 60% sensitive and ≥ 99.8% specific, while to support stopping decisions, the test must be ≥ 89% sensitive and ≥ 99.8% specific. The requirement for extremely high specificity is dictated by the need to detect with sufficient statistical confidence the low seroprevalence threshold set by WHO. Surveys designed to detect a 1-2% prevalence of a given biomarker, as is the case here, cannot tolerate more than 0.2% of false-positives. Otherwise, the background noise would drown out the signal. It is recognized that reaching and demonstrating such a stringent specificity criterion will be challenging, but test developers can expect to be assisted by national governments and implementing partners for adequately powered field validation.

Original languageEnglish
Article numbere0010682
Pages (from-to)1-18
Number of pages18
JournalPLoS Neglected Tropical Diseases
Volume16
Issue number8
DOIs
Publication statusPublished - 3 Aug 2022

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